Field
The present application is directed to a system for collecting an endometrial tissue sample, and more particularly to a non-invasive endometrial sample collector.
Description of the Related Art
There are several existing procedures for obtaining samples of endometrial tissue. One such procedure involves the sampling of the endometrium with a small plastic device that is introduced in the uterine cavity and through the uterine cervix in order to obtain the tissue sample. This procedure is usually performed in a doctor's office, without anesthesia.
Another existing procedure for obtaining an endometrial tissue sample involves cervical dilation and curettage (D&C). The D&C procedure requires insertion of instruments (e.g., curette or sharp curettage, suction curettage, electric vacuum aspiration) in the uterine cavity and through the uterine cervix to remove endometrial tissue samples, such as by scraping and scooping the endometrial tissue sample. This procedure is performed in a hospital, under anesthesia. The procedure is often performed blindly by the doctor (e.g., without the use of any imaging technique such as ultrasound or hysteroscopy).
Still another existing procedure for obtaining an endometrial tissue sample involves a hysteroscopy. This procedure involves introducing an optical system (e.g., endoscope) within the uterine cavity and through the uterine cervix to directly observe the endometrium. The endoscope can have operative channels through which instruments (e.g., biopsy instruments, resectoscope) can be deployed to obtain a sample of the endometrial tissue under the visual guidance provided by the optical system. Such a procedure can be performed at a hospital or surgical centers, or a clinic, and can be performed under local anesthesia. Hysteroscopies are more expensive procedures (from the patient's and doctor's point of view) since they require expensive equipment and trained specialists.
All of the above described existing procedures for obtaining endometrial tissue samples have numerous disadvantages and potential risks to the patient, including: the risk of infection (e.g., due to the introduction of instruments into the vaginal cavity); the risk of perforating the endometrium and uterine wall (e.g., and possibly damage other organs, such as the intestines); severe bleeding (even in the absence of perforation of the endometrium); endometrial lesions by scarring, leading to infertility (i.e., Asherman's Syndrome); the risk of interrupting an existing but undiagnosed pregnancy; the risk of side effects from antibiotics or pain medication; the risks associated with anesthesia; pain and/or discomfort to the patient; interruption of sexual activity following the procedure; interruption of work and/or social activity for the patient following the procedure; and the risk of allergic reactions to drugs (e.g., antibiotics, analgesic, anesthesia, etc.), iodine (used for cleaning the uterine cervix and vagina during the procedure), latex (e.g., surgical gloves). Other drawbacks of existing procedures include the amount of time the procedures take, the elevated cost of the procedures and the complications they cause in the patient's lives (e.g., anxiety, interruption of work, family interactions and sexual activity).